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Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

NCT02137850 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-12-23

Study results available
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Summary

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A

Interventions

DRUG

turoctocog alfa pegol

For intravenous (i.v.) injection. Frequency and dosage (20-75 U/kg) dependent on whether given as treatment for bleeding episode or as prophylaxis

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
6 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-26
Primary Completion
2023-06-07
Completion
2023-06-07

Countries

  • United States
  • Algeria
  • Argentina
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Portugal
  • Puerto Rico
  • Romania
  • Serbia
  • Spain
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02137850 on ClinicalTrials.gov